The following data is part of a premarket notification filed by Medical Park Co., Ltd with the FDA for Bexcore Breast Biopsy System, Biopsy Needle.
| Device ID | K171890 |
| 510k Number | K171890 |
| Device Name: | BEXCORE Breast Biopsy System, Biopsy Needle |
| Classification | Instrument, Biopsy |
| Applicant | Medical Park CO., LTD #624, Knowlegdge Industry Center Bundang-Suji, U-Tower 767,Sinsu-ro, Suji-gu Yongin-si, KR |
| Contact | Hye-yeon Park |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-26 |
| Decision Date | 2018-08-20 |
| Summary: | summary |